Kornimate/medical-research-clean huggingface dataset:
the effect of mindfulness on psychophysiological stress in a population with elevated stress symptoms

Conditions: Psychological Stress; Physiological Stress

Summary: stress-related disorders have over the last decade increased and contributed to a worldwide disease burden. at the same time there is limited treatment access for mental health disorders, which has left many people without necessary care. however, in recent years there has been a rise in digital mindfulness interventions. specifically, these interventions have focused on smartphone-based applications as an effective format for mindfulness training programs. thus, the goal of this randomized controlled trial is to test the effects of three types of mindfulness programs in a population with elevated stress. the three formats of mindfulness interventions are identical in total training duration but varies in content and intervention length. specifically, the first intervention consists of programmatic mindfulness content that progress over the course of 30 sessions with a duration of 10 min per session. the second intervention consists of single succinct breathing exercises with no programmatic content over the course of 30 sessions with a duration of 10 min per session. the third intervention consists of mindfulness-based content specifically targeted to people with elevated stress that progress over the course of 20 sessions with a duration of 15 min per session. an active control group listening to an audiobook over the course of 30 sessions with a duration of 10 min per session will be employed and a passive control group. the study will evaluate outcomes related to subjective stress, sleep quality, mindfulness and physiological effects of stress using hrv.


Eligibility criteria:
inclusion criteria: * moderate to high perceived stress based on pss total scores (14-40) * fluent in english exclusion criteria: * regular mindfulness practice for more than 1 month within the last year * medical diagnosis e.g. psychiatric/neurological conditions * low levels of stress (i.e., less than a score of 14 assessed with the pss)

Keywords: stress mindfulness hrv
inhaled nitric oxide (ino) for the prevention of bronchopulmonary dysplasia (bpd) in preterm infants

Conditions: Bronchopulmonary Dysplasia

Summary: this phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with ino.

multi-center, double blind, placebo-controlled, randomized clinical trial. infants who meet all enrollment criteria at any point during days 5 to 14 after birth will be randomized to inhaled no starting at 20 ppm, or matching placebo, by means of a blinded inovent® delivery device. all infants will receive 24 days of therapy, following a dose reduction schedule. infants who are extubated before 24 days will continue therapy via nasal continuous positive airway pressure (cpap) or nasal cannula to complete 24 days' of therapy. the primary outcome measure will be survival without bpd at 36 weeks gestational age using a physiologic assessment of bpd.

Eligibility criteria:
inclusion criteria: * preterm infants who are: 1. 500 to 1250 grams at birth 2. \< 30 weeks gestational age 3. 5 to 14 days of age (inclusive) at the time of entry 4. requiring mechanical ventilation or for those infants ≤ 800 grams, positive pressure support (including cpap) for respiratory insufficiency on days 5 to 14 days of age (inclusive) exclusion criteria: 1. preterm infants with life-threatening anomalies (cranial, cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any subject who will not receive complete intensive care 2. preterm infants with bilateral grade 4 intraventricular hemorrhage (ivh) 3. subjects who are dependent on right to left shunting to maintain the systemic circulation 4. preterm infants who received prior ino therapy 5. use of another investigational agent

Keywords: bronchopulmonary dysplasia, bpd
a study to evaluate ombitasvir/paritaprevir/ritonavir and dasabuvir in treatment-naïve hepatitis c virus genotype 1b-infected adults

Conditions: Hepatitis C Infection; Hepatitis C Virus

Summary: this study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (gt1b) hepatitis c virus (hcv).


Eligibility criteria:
inclusion criteria: 1. chronic hcv infection at screening. 2. screening laboratory result indicating hcv genotype 1b infection. 3. treatment-naïve and non-cirrhotic. exclusion criteria: 1. hcv genotype or subtype other than gt1b. 2. positive test result for hepatitis b surface antigen (hbsag) or confirmed positive anti-hiv antibody (hiv ab) test. 3. any current or past clinical evidence of cirrhosis. 4. screening laboratory analyses that shows abnormal results. 5. clinically significant abnormalities or co-morbidities, other than hcv infection that make the participant an unsuitable candidate for this study.

Keywords: hepatitis c virus interferon-free ribavirin-free hepatitis c hepatitis c genotype 1b
tumor vaccine and interferon gamma in treating patients with refractory epithelial ovarian cancer

Conditions: Recurrent Ovarian Epithelial Cancer

Summary: phase i trial to study the effectiveness of a tumor cell vaccine and interferon gamma in patients with refractory epithelial ovarian cancer. vaccines made from a person's cancer cells may make the body build an immune response to and kill their tumor cells. combining vaccine therapy with interferon gamma may be a more effective treatment for epithelial ovarian cancer

objectives: i. determine whether intraperitoneal (ip) injections of epithelial ovarian carcinoma cells infected with alvac-hb7.1 and ip interferon gamma have acceptable toxicity and produce any clinical responses in patients with refractory ovarian epithelial cancer. outline: this is a dose-escalation study of alvac-hb7.1 infected tumor cells. patients receive alvac-hb7.1 infected tumor cells intraperitoneally (ip) on days 4, 11, and 18. patients also receive interferon gamma ip on days 8, 10, 15, and 17. in the absence of disease progression, up to 6 courses of therapy may be given. if insufficient tumor cells are available to continue treatment with tumor cell derived vaccine, interferon gamma may be given alone. cohorts of 3 to 6 patients receive escalating doses of alvac-hb7.1 infected tumor cells until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity. patients are followed every 6 months until disease progression. projected accrual: a total of 12 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * diagnosis of ovarian epithelial carcinoma * previously treated with an adequate course of platinum based chemotherapy * evidence of intraabdominal disease * no significant adhesions * performance status - zubrod 0-2 * lymphocyte count at least 500/mm\^3 * bilirubin no greater than 1.5 mg/dl * sgot less than 2.5 times upper limit of normal * creatinine no greater than 1.5 mg/dl * no major disorder of the cardiovascular system * no major disorder of the pulmonary system * not pregnant or nursing * fertile patients must use effective contraception * successful placement of peritoneal catheter * no overt autoimmune disease * no concurrent chronic steroid therapy * no prior radiotherapy * prior surgery allowed * recovered from prior therapy
herceptin (trastuzumab) in treating women with human epidermal growth factor receptor (her) 2-positive primary breast cancer

Conditions: Breast Cancer

Summary: the purpose of this trial is to evaluate herceptin treatment for 1 year and 2 years (versus observation/no herceptin) in women with her2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable. efficacy and safety will be assessed for 10 years from randomization for each participant. all participants will continue to be followed for survival until 10 years after enrollment of the last participant.


Eligibility criteria:
inclusion criteria: * non-metastatic primary invasive breast cancer overexpressing her2 (determined by immunohistochemistry 3+ or positive fluorescence in situ hybridization test) that has been histologically confirmed, adequately excised, axillary node positive or negative, and tumor size at least t1c according to tumor/node/metastasis (tnm) staging * completion of at least 4 cycles of (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable * known hormone receptor status * baseline left ventricular ejection fraction (lvef) greater than or equal to (≥) 55 percent (%) exclusion criteria: * prior invasive breast carcinoma * other malignancies except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix * clinical t4 tumors * cumulative doxorubicin exposure greater than (\>) 360 milligrams per meter-squared (mg/m\^2) or epirubicin \>720 mg/m\^2 or any prior anthracyclines unrelated to the present breast cancer * peripheral stem cell or bone marrow stem cell support * prior mediastinal irradiation except for internal mammary node irradiation for the present breast cancer * non-irradiated internal mammary nodes or supraclavicular lymph node involvement * prior anti-her2 therapy for any other reason or other prior biologic or immunotherapy for breast cancer * concurrent anti-cancer treatment in another investigational trial * serious cardiac or pulmonary conditions/illness, or any other conditions that could interfere with planned treatment * poor hematologic, hepatic, or renal function * pregnancy or lactation * women of childbearing potential or less than 1 year post-menopause unwilling to use adequate contraceptive measures
beta-cit-spect and neurophysiology in depression

Conditions: Depression

Summary: aim of this project is to investigate the effects of escitalopram on monoamine transporter (sert, dat) availabilities as assessed by b-cit and spect, and on neurophysiological parameters such as the loudness dependence of auditory evoked potentials (ldaep) in patients with depression.


Eligibility criteria:
inclusion criteria: * psychiatric in or outpatients with acute depressive episode * indication for pharmacological treatment exclusion criteria: * acute suicidality * neurological or severe somatic disorders * occupational exposition to radiation \>15 msv per year * women during pregnancy or lactation

Keywords: depression β-cit-spect sert dat neurophysiology ldaep escitalopram ssri
assessment of acute renal injury during partial nephrectomy using neutrophil gelatinase-associated lipocalin (ngal): prospective comparative study between open, video-assisted minilaparotomy, laparoscopic, and robotic-assisted laparoscopic surgery

Conditions: the Patients With Partial Nephrectomy

Summary: urinary neutrophil gelatinase associated lipocalin (ngal) has been recently reported to be related with the degree of acute kidney injury. we are trying to analyze whether it is related with the grade of acute kiney injury after partial nephrectomy and there is any difference between the kinds of surgery.


Eligibility criteria:
inclusion criteria: 1. adults patient more than 20 years old with asa score 1-3 2. the patients who undergoing partial nephrectomy for the renal mass less than 7 cm exclusion criteria: 1. the patient with previous history with renal surgery 2. the patient with bilateral partial nephrectomy 3. the patient with synchronous operation for other intraperitoneal surgery 4. the renal mass more than 7 cm 5. previous kinds of surgery is changed into other kinds due to bleeding, etc 6. the patient with serum cr level more than 1.4 mg/dl 7. the patient who does not understand the consent form

Keywords: acute kidney injury, partial nephrectomy, biomarker
preoperative 5-day radiotherapy for soft tissue sarcoma

Conditions: Soft Tissue Sarcoma

Summary: the purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and/or leg(s) using hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body.

this study is for subjects that have been diagnosed with cancer in their arm, leg, or trunk (the part of the body that involves the chest, abdomen, and pelvis). the purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and/or leg(s) using hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body. this study will look at early side effects and effectiveness of preoperative 5-day hypofractionated radiotherapy. active participation in the study will take about 12 visits and are completed once the participant has a 6-month post-operation visit.

Eligibility criteria:
inclusion criteria: * willingness and provision of informed consent via signed and dated copy. * histologically confirmed sts of extremity or trunk. * male or female, aged greater than or equal to 18 years old * ecog performance status 0-3 * meets screening criteria for receipt of radiotherapy. * deemed eligible for wide local excision. * patient and/or physician identified possible barriers to receiving a 5-week course of conventionally fractionated preoperative radiotherapy. potential barriers include but are not limited to concern for local progression that could precluded or complicate limb sparing surgery, concern for distant progression that could result in patient being non-operative, financial and/or physical burden of travel for daily treatments, financial burden of time away from work or caregiving. exclusion criteria: * distant metastatic disease * prior radiation therapy in the proposed treatment area * simultaneous treatment of another malignancy * women who are pregnant or plan to become pregnant during the period of radiation therapy * planned concurrent administration of chemotherapy and radiation therapy

Keywords: sts hfrt sfrp2
the use of surfactant in lung transplantation: a randomized control pilot study

Conditions: Lung Transplantation; Primary Graft Dysfunction

Summary: 1. working hypothesis: the purpose of the trial is to study the effect of exogenous calf surfactant (calfactant) on the prevention of primary graft failure due to ischemic-reperfusion lung injury in lung transplant patients. 2. aims of the study: the purpose of the trial is to study the effect of exogenous calf surfactant (calfactant) on the prevention of primary graft failure due to ischemic-reperfusion lung injury in lung transplant patients.

background: lung transplantation induces surfactant dysfunction that may be a contributing factor for primary graft dysfunction (pgd) and graft failure. animal studies and limited human reports suggest that surfactant administration may prevent primary graft dysfunction. working hypothesis and aims: the purpose of the trial is to study the effect of exogenous calf surfactant (calfactant) on the prevention of primary graft failure due to ischemic-reperfusion lung injury in lung transplant patients. methods: the trial is an open randomized controlled prospective study. patient population: 42 patients eligible for lung transplant according to hospital criteria. study medication: calfactant intratracheal suspension -an extract of natural surfactant from calf lungs, which includes phospholipids, neutral lipids and surfactant-associated proteins b and c (sp-b and sp-c). study design: patients randomized to receive calfactant will have the drug administered through a fiberoptic bronchoscope distributing the drug evenly across the lung immediately after connection. the other patient will not have any administration to avoid any excessive flushing. when 2 lungs will be used from the same donor for 2 recipients one patient receiving one lung will be treated with calfactant while the other patient receiving the other lung will not be treated and serve as the control. otherwise lungs will be treated with surfactant in every other case. expected results: we expect surfactant instillation during lung transplantation to improve oxygenation, prevent primary graft dysfunction, make intubation time shorter and to enhance early post transplantation recovery. in a pilot study that we already performed results are encouraging. importance: pgd could cause substantial morbidity and mortality among transplanted patients. in a pilot study we already found that surfactant instillation during lung transplantation improves oxygenation, prevents primary graft dysfunction, shortens intubation time and icu stay. we believe that surfactant treatment enhances early post transplantation recovery, and may also be cost effective by shortening expensive icu stay.

Eligibility criteria:
inclusion criteria: * candidates for lung transplantation exclusion criteria: * differential diagnosis of pgd * pulmonary edema * stenosis or thrombosis of pulmonary artery/vein anastomosis

Keywords: pulmonary surfactants lung transplantation primary graft dysfunction
covid-19 vaccine effectiveness against recurrent infection among lung cancer patients and biomarker research

Conditions: COVID-19 Recurrent; Lung Cancer; Vaccination; Antibody; Chemotherapy; Immune Checkpoint Inhibitor

Summary: a prospective, open-label and parallel non-randomized control trial and biomarker research study is intended to compare incidence of repeated covid-19 infection, severe pneumonitis and mortality between lung cancer patients undergoing systemic antitumor therapies who get vaccinated with 1 booster dose(majorly against xbb) and those who refuse. meanwhile, a biomarker research is designed to monitor serum level dynamics of specific antibodies against covid-19,analyze its correlation with incidence of breakthrough infection and further explore optimal periods for vaccination.

a single booster dose will be administered depending on patients' willingness in the sixth month after symptomatic covid-19 infection and status including repeated covid19 infection, critical and/or severe conditions and all-cause death will be recorded during the next 6 months after vaccination or not. for antibody analysis, 5 ml blood samples will be collected from all of the included patients respectively in the 3rd ,4.5th and 6th months after latest occurrence of symptomatic infection and at the same timepoints after booster dose vaccination.

Eligibility criteria:
inclusion criteria: 1. patients who agree to participate in the trial and sign the informed consents. 2. male or female, ≥18 years old. 3. diagnosed of lung carcinoma by histological and cytological examinations. 4. undergoing systemic anti-tumor treatments including chemotherapy, immunotherapy, chemoimmunotherapy and targeted therapy. 5. recorded history of covid19 infection. 6. sufficiently functional organs. 7. eastern cooperative oncology group performance score (ps) ranging from 0 to 2. exclusion criteria: 1. life expectance less than 3 months. 2. less than 3 months since last confirmed covid-19 infection. 3. patients unable to return the hospital for follow-up. 4. patients allergic to covid-19 vaccine. 5. patients with histories of severe treatment-related adverse events graded 3rd or higher, including those caused by antitumor therapies or immunization except recoverable granulocytopenia.
development and validation of a digital pain-reduction kit for musculoskeletal injuries

Conditions: Pain, Acute; Pain, Chronic

Summary: this study will test the effectiveness of an evidence-based, multi-modal, "digital pain-reduction kit" as a non-pharmacological supplement to managing patients with pain due to musculoskeletal injuries. outpatients will be randomized to receive either the pain reduction kit or active control. the kit will contain a virtual reality (vr) headset, therapeutic vr visualization software, and a low-cost wearable transcutaneous electrical nerve stimulation (tens) unit. clinical staff will monitor progress and provide scheduled coaching and outreach to patients in the intervention group. the control group will receive the low-cost wearable transcutaneous electrical nerve stimulation (tens) unit alone; they will not receive vr or remote coaching. study devices will be delivered to the patient's home with instructions for use; patients will receive remote clinical and technical support. patients will be followed for 60 days and monitored for functional status, pain levels, use of pain medications (including opioids), satisfaction with care, and time to returning to work.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, age 18 or older 4. seeking care for a musculoskeletal injury 5. experiencing pain greater than 3 out of 10 on a visual analog scale 6. english or spanish speaking 7. owns a compatible android or ios smartphone device (excluding tablets) exclusion criteria: 1. unable to understand the goals of the study due to cognitive difficulty 2. use of a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device or high-frequency surgical equipment. (contraindication for tens units) 3. pregnant (contraindication for tens unit) 4. current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of vr hardware or software 5. hypersensitivity to flashing light or motion 6. injury to the eyes, face, neck, or arms that prevents comfortable use of vr hardware or software, or safe use of other study hardware (e.g., open sores, wounds, or skin rash on face)

Keywords: virtual reality transcutaneous electrical nerve stimulation analgesia